论文部分内容阅读
作者比较甲氟喹与周效磺胺-乙胺嘧啶的安全性及耐受量,采用随机双盲的Ⅰ期临床试验。受试者共20例,均为男性成人,大多来自巴西的帕拉戈明纳斯疟疾流行区。试验前4周,受试者未曾服用抗疟药物。受试期间住入特别设计的防蚊病室。共观察66天,其中,包括2天基础研究与服药后的63天随访。服药:10例受试者,每人接受甲氟喹4片,每片含量250mg,及安慰剂2片;其余10例,每例给予周效磺胺-乙胺嘧啶2片(每片含周效磺胺500mg,乙胺嘧啶25mg)及安慰剂4片。均为一次口服。
The authors compared the safety and tolerability of mefloquine with psoxamine-pyrimethamine, using a randomized, double-blind Phase I clinical trial. A total of 20 subjects were male adults, mostly from the endemic area of Palago Minas in Brazil. Four weeks prior to the test, the subject did not take antimalarial drugs. During the test period into the specially designed mosquito wards. A total of 66 days were observed, including 2 days of basic research and 63 days after treatment. Medication: 10 subjects, each received mefloquine 4 tablets, each tablet content 250mg, and placebo 2 tablets; the remaining 10 cases, each given weekly sulfonamide - pyrimethamine 2 tablets Sulfonamide 500mg, pyrimethamine 25mg) and placebo 4 tablets. All oral once.